BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 1041559 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31976
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    August 27, 2007
    Report Date
    August 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED EVALUATING THE LEAD BY PERFORMING A MAXIMUM ENERGY SHOCK. TS ALSO DISCUSSED THAT EITHER A LOW OR HIGH SHOCK IMPEDANCE WOULD CAUSE THE DEVICE TO BEEP. ADDITIONAL INFORMATION WAS PROVIDED THAT A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS PERFORMED TO TEST THE SHOCK SYSTEM INTEGRITY, AND THE SHOCK IMPEDANCE WAS NORMAL ON BOTH THE HIGH AND LOW ENERGY SHOCKS; THE DEVICE WAS FUNCTIONING NORMALLY. TS RECOMMENDED CONTINUED MONITORING OF THE PATIENT AT THAT TIME. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN SERVICE WITHOUT ADDITIONAL COMPLICATION. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THREE SEGMENTS OF THE TERMINAL CONNECTOR WERE RETURNED; THE DF-1 DISTAL LEG WAS SEVERED 4.5 CM FROM THE TERMINAL PIN, THE DF-1 PROXIMAL PORTION WAS SEVERED 4.5 CM FROM THE TERMINAL PIN, AND THE IS-1 LEG WAS RETURNED SEVERED 5 CM FROM THE TERMINAL PIN. THERE WERE SETSCREW MARKS NOTED ON ALL THE TERMINAL CONNECTORS. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE, AND MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO CONFIRM THE FIELD OBSERVATIONS THROUGH TESTING ON THE RETURNED LEAD SEGMENTS.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS DETECTED BY THE LATITUDE SYSTEM FROM THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO A LOW SHOCK IMPEDANCE MEASUREMENT. ADDITIONAL INFORMATION WAS PROVIDED THAT ANOTHER LOW SHOCK IMPEDANCE MEASUREMENT WAS RECORDED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION. IN 2014, THE DEVICE SYSTEM WAS RETURNED FOR ANALYSIS. FURTHER INVESTIGATION WAS DONE AND REVEALED THE PATIENT HAD DIED IN MAY 2008. THERE WERE NO ALLEGATIONS RECEIVED THAT THE DEVICE SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FUNERAL HOME THAT RETURNED THE DEVICE; THE PRIMARY CAUSE OF DEATH WAS CARDIOGENIC SHOCK AND CONGESTIVE HEART FAILURE, AND THE SECONDARY CAUSE WAS LISTED AS ISCHEMIC CARDIOMYOPATHY AND CORONARY ARTERY DISEASE. REPORTEDLY NO AUTOPSY WAS PERFORMED AND THE MANNER OF DEATH WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other THE DEVICE H175/100741 WAS IMPLANTED (B)(6) 2003| THE DEVICE 6481 013257 WAS USED DURING THE EVENT.| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6481 013257 WAS USED DURING THE EVENT.| THE DEVICE 4243/313557 WAS IMPLANTED (B)(6) 1999| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4513/400236 WAS IMPLANTED 20-AUG-2003| THE DEVICE 4243/313557 WAS IMPLANTED 16-MAR-1999| THE DEVICE 4513/400236 WAS IMPLANTED (B)(6) 2003| THE DEVICE H175/100741 WAS IMPLANTED 14-AUG-2003